Tubular implantable sling and related delivery systems, methods and devices

ABSTRACT

The invention generally relates to surgically implantable supportive slings. More specifically, in various embodiments, the invention is directed to systems, devices and methods relating to a surgically implantable supportive sling having an adjustable shape.

FIELD OF THE INVENTION

The invention generally relates to surgically implantable supportiveslings. More specifically, in various embodiments, the invention isdirected to systems, devices and methods relating to a surgicallyimplantable shape adjustable supportive sling.

BACKGROUND

Urinary incontinence affects over 13 million men and women of all agesin the United States. Stress urinary incontinence (SUI) affectsprimarily women and is generally caused by two conditions, intrinsicsphincter deficiency (ISD) and hypermobility. These conditions may occurindependently or in combination. In ISD, the urinary sphincter valve,located within the urethra, fails to close properly (coapt), causingurine to leak out of the urethra during stressful activity.Hypermobility is a condition in which the pelvic floor is distended,weakened, or damaged, causing the bladder neck and proximal urethra torotate and descend in response to increases in intra-abdominal pressure(e.g., due to sneezing, coughing, straining, etc.). The result is thatthere is an insufficient response time to promote urethral closure and,consequently, urine leakage and/or flow results.

A popular treatment of SUI is the use of a sling, which is permanentlyplaced under a patient's bladder neck or mid-urethra to provide aurethral platform. Placement of the sling limits the endopelvic fasciadrop, while providing compression to the urethral sphincter to improvecoaptation. Generally, the sling is surgically placed under urethra,close to the high-pressure zone with no elevation of the urethra. Theends of a sling are secured to an anatomical location by, for example, abone anchor. Recent advances in surgical techniques have demonstratedthe effectiveness of approaches without employing bone anchors towardmid-urethra sling stabilization. However, the bone anchor-lesstechniques typically require the use of large diameter delivery devices.For example, some procedures require 1/8 to 1/4 inch diameter deliverydevices to create a tract in which the sling would lie. Such a largetract may cause the patients pain for weeks. Further, the typical slingmade from woven mesh may also narrow when tensioned during placement,which results in less stable placement in tissue.

Accordingly, there is a need for an improved surgically implantablesling or sling-like support having a low profile, and which does notnarrow during placement.

SUMMARY OF THE INVENTION

The invention addresses the deficiencies of the prior art by providingimproved devices, systems and methods relating to an implantable slingfor supporting an anatomical site in the body of a patient. Moreparticularly, in various embodiments, the invention provides asupportive sling that can be inserted into the body of a patient in alow width state, and subsequent to insertion into the body, can bereconfigured to have a larger width sized appropriately for supportingthe anatomical site. According to one embodiment, in the low widthstate, the sling has an increased length. As the length is decreasedsubsequent to insertion, the width increases. According to oneadvantage, the sling can be transitioned from between the first andsecond states without damaging the sling. According to anotheradvantage, the transitioning between the first and second states alsoprovides a mechanism for tensioning the sling under the anatomical sitebeing supported. The sling of the invention may be used to support anysuitable internal anatomical site. However, in some embodiments, thesling of the invention may be employed, for example, for providing aurethral support to treat urinary incontinence or for pelvic floorreconstruction.

In one aspect, a sling assembly of the invention includes an implantablesupportive sling having a tubular shape defining an outer side forsupporting an anatomical site in a patient, an inner side and an axialpassage extending on the inner side between first and second ends. Thesling assembly also includes a first tensioning filament attached at thefirst end of the sling and extending through the axial passage and outthe second end of the sling, and a second tensioning filament attachedto the second end of the sling and extending through the axial passageand out the second end of the sling.

According to one embodiment, the sling assembly includes a firsttensioning filament attached at the first end of the sling, extendingthrough the axial passage, and out the sling mesh at a point other thanthe second end of the sling. For example, the first tensioning filamentmay extend through the axial passage and out the sling mesh atapproximately the midpoint of the sling. The sling assembly furtherincludes a second tensioning filament attached to the second end of thesling, extending through the axial passage, and out the sling mesh at apoint other than the second end of the sling. For example, the secondtensioning filament may extend through the axial passage and out thesling mesh at approximately the midpoint of the sling.

According to one embodiment, the sling assembly also includes a firstend cap attached to the first end of the sling and a second end capattached to the second end of the sling, the first and second end capshaving through apertures. In one configuration, the first tensioningfilament attaches to the first end of the sling by way of the first endcap and extends out of the second end of the sling by way of the throughaperture of the second end cap. Similarly, the second tensioningfilament attaches to the second end of the sling by way of the secondend cap and extends out of the first end of the sling by way of thethrough aperture of the first end cap. According to a furtherconfiguration, the first and second filaments attach to inner surfacesof the respective first and second end caps. In some configurations, theend caps are tapered to provide tissue dilation during insertion of thesling assembly ends into the body of the patient.

In operation, pulling on a terminal end of the first tensioning filamentwhile holding a terminal end of the second tensioning filamentstationary draws the first end cap axially along the second tensioningfilament to effectively shorten the length of the sling. Due to thetubular configuration of the sling, this pulling also causes the widthof the sling along at least a middle portion to widen. Similarly,pulling on the terminal end of the second tensioning filament whileholding the terminal end of the first tensioning filament stationarydraws the second end cap axially along the first tensioning filament,once again to effectively shorten the length and increase the width ofthe sling.

The sling of the sling assembly may be made of any suitable material.However, in preferred embodiments, the sling is formed from a woven ormesh material. The woven or mesh material enables the sling totransition easily between various lengths and widths as described above,without twisting, folding or otherwise becoming tangled, damaged orundesirably distorted.

According to a further embodiment, the sling assembly may include anysuitable association mechanisms attached to the terminal ends of thefirst and second tensioning filaments for associating the sling assemblyof the invention with a suitable delivery device. At one end of thespectrum, such association mechanisms may provide, for example,relatively loose slidable associations with a delivery device, oralternatively, relatively secure, fixed attachments to such deliverydevices. According to one embodiment, first and second soft tissueanchors attach to respective terminal ends of the first and secondtensioning filaments. Any suitable delivery device may engage with thesoft tissue anchors to deliver them to a desired anatomical location.

According to a further aspect, the invention provides a delivery devicefor delivering the sling assembly of the invention to a desiredanatomical location. In this aspect, the delivery device includes ahandle, and a shaft extending distally from a distal end of the handle.The shaft includes a shaft lumen axially extending near a distal end ofthe shaft, the shaft lumen being sized and shaped for slidably receivingan anchor of a sling assembly. The shaft also includes a slot extendingaxially along at least a portion of the shaft lumen, the slot beingsized and shaped for slidably receiving a filament attached to theanchor received in the shaft lumen.

According to one embodiment, the shaft lumen extends axially into theshaft from an opening in the distal end of the shaft, with the openingbeing sized and shaped for receiving the anchor of the sling assemblyinto the shaft lumen. In one configuration, the slot extends axially ina proximal direction from the opening in the distal end of the shaft.According to one construction, the slot extends proximally for an entirelength of the shaft lumen. However, in an alternative construction, theslot extends proximally for only a portion of the length of the shaftlumen.

According to another embodiment, the handle includes a handle lumenextending axially through the handle and the shaft lumen extendsdistally to a distal end of the shaft and axially aligns with the handlelumen. According to one feature of this embodiment, the delivery deviceincludes a pusher assembly. The pusher assembly includes a pusher and auser actuator for sliding the pusher axially within the shaft and handlelumens.

According to a further embodiment, the delivery device includes a notchhaving a width greater than the width of the slot, located along aportion of the shaft lumen, and extending axially from an end of theslot. The notch may extend proximally from a proximal end of the slot ordistally from a distal end of the slot. According to variousconfigurations, the shaft lumen may extend distally from a distal end ofthe notch or proximally from a proximal end of the notch. In someembodiments, the shaft lumen extends distally to an opening in a distalend of the shaft. Preferably, the opening is sized and shaped forreceiving the anchor of the sling assembly into the shaft lumen.According to one feature, the delivery device of this embodimentincludes an alternative pusher sized and shaped for insertion into theopening in the distal end of the shaft and for extending at least to adistal end of the notch.

According to another aspect, the shaft of the delivery device of theinvention includes a shaft lumen axially extending near a distal end ofthe shaft, with the shaft lumen sized and shaped for slidablyinterfitting with an anchor of a sling assembly. The shaft also includesa notch extending axially along at least a portion of the shaft lumen,with the notch sized and shaped for receiving an anchor of a slingassembly into the shaft lumen. In one embodiment of this aspect, thehandle of the delivery device includes a handle lumen extending axiallythrough the handle, and the shaft lumen extends distally to a distal endof the shaft and axially aligns with the handle lumen. According to afurther embodiment, the delivery device includes a cannula assembly, thecannula assembly including a cannula and a user actuator for sliding thecannula axially within the shaft and handle lumens at least partiallyinto the notch.

According to another aspect, the invention provides a system fortreating urinary incontinence. The system includes a sling assembly,which includes an implantable supportive sling having a tubular shapedefining an outer side for supporting a urethra of a patient, an innerside and an axial passage extending on the inner side between first andsecond ends, a first tensioning filament attached at the first end ofthe sling and extending through the axial passage and out the second endof the sling, and a second tensioning filament attached to the secondend of the sling and extending through the axial passage and out thesecond end of the sling. The system further includes a delivery devicefor implanting the sling in periurethral tissues of the patient toameliorate urinary incontinence.

According to one embodiment, a sling assembly of a system of theinvention includes a first anchor attached to a terminal end of thefirst tensioning filament and a second anchor attached to a terminal endof the second tensioning filament.

According to one embodiment, a delivery device of a system of theinvention includes a handle and a shaft extending distally from a distalend of the handle and including, a shaft lumen axially extending near adistal end of the shaft, the shaft lumen being sized and shaped forslidably receiving at least one of the first and second anchors of thesling assembly, and a slot extending axially along at least a portion ofthe shaft lumen, the slot being sized and shaped for slidably receivingat least one of the first and second tensioning filaments.

According to another embodiment, a delivery device of a system of theinvention includes a handle and a shaft extending distally from a distalend of the handle and including, a shaft lumen axially extending near adistal end of the shaft, the shaft lumen being sized and shaped forslidably interfitting with at least one of the first and second anchorsof the sling assembly, and a notch extending axially along at least aportion of the shaft lumen, the notch being sized and shaped forreceiving at least one of the first and second anchors of a slingassembly into the shaft lumen.

A further aspect of the invention provides a method for treating urinaryincontinence or for pelvic floor reconstruction. According to oneembodiment, a method of the invention includes delivering a first end ofa sling assembly including a first end of a supportive sling to a firstanatomical site in a body of a patient. The method includes delivering asecond end of the sling assembly to a second anatomical site in thepatient to draw the first end of the supportive sling along a tensioningfilament attached to the second end of the sling assembly to reduce alength and increase a width of the sling as distance increases betweenthe first and second anatomical sites to ameliorate urinaryincontinence.

The foregoing and other objects, features, and advantages of theinvention will become more apparent from the following description andfrom the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Various illustrative systems, methods, devices, features and advantagesof the invention are described below with reference to the appendeddrawings, which may not be drawn to scale and in which like parts aredesignated by like reference designations.

FIG. 1A depicts a tubular sling assembly in an unexpanded stateaccording to an illustrative embodiment of the invention.

FIG. 1B depicts a tubular sling assembly in an expanded state accordingto an illustrative embodiment of the invention.

FIG. 1C depicts a tubular sling assembly in an expanded state accordingto an alternative illustrative embodiment of the invention.

FIG. 2 depicts a system for delivering a tubular sling assembly to ananatomical site including a delivery device having a shaft with anaxially extending slot in a distal portion for engaging with a T-anchorand tensioning suture of the sling assembly according to an illustrativeembodiment of the invention.

FIG. 3 depicts an alternative system for delivering a tubular slingassembly to an anatomical site including a delivery device having ashaft with a notch and at least one axially extending slot along a sideof a distal portion for engaging with a T-anchor and suture of the slingassembly according to an illustrative embodiment of the invention.

FIG. 4 depicts another alternative system for delivering a tubular slingassembly to an anatomical site including a delivery device having ahollow shaft with a notch along a side portion for seating a T-anchorand an inner cannula for extending within the hollow shaft and over theseated T-anchor to maintain the T-anchor within the shaft according toan illustrative embodiment of the invention.

FIG. 5 shows the distal end of an exemplary delivery device shaft fordelivering a sling assembly of the type shown in FIG. 1C.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

As described in summary above, in various illustrative embodiments, theinvention is directed to a sling assembly including a supportive andimplantable sling having tubular configuration in which filaments may beoperator actuated to transition the sling from an elongatedwidth-contracted state to a shorter width-expanded state. In otherillustrative embodiments, the invention is directed to delivery devicesfor delivering the sling of the invention, anchors for anchoring thesling in place, various association members for associating the slingassembly of the invention with a suitable delivery device, and kitsincluding a delivery device and sling assembly of the invention.

FIG. 1A depicts a sling assembly 100 in an untensioned state accordingto an illustrative embodiment of the invention. As shown, the slingassembly 100 includes: a tubular and implantable sling 102; two dilators104 and 106 located at either end 102 a and 102 b, respectively, of thesling 102; two anchors 108 and 110; and two tensioning filaments 112 and114. FIG. 1B depicts the sling 100 in a more or fully tensioned stateaccording to an illustrative embodiment of the invention. FIG. 1Cdepicts the sling assembly 100 in a more or fully tensioned stateaccording to an alternative illustrative embodiment of the invention.Referring to FIGS. 1A, 1B, and 1C, the dilator 104 has a generallycylindrical portion 104 a and a generally conical portion 104 bextending axially from the cylindrical portion 104 a. The conicalportion 104 b tapers smaller toward and terminates in an aperture 104 c.A terminal end 104 d of the cylindrical portion 104 a bonds to the end102 a of the tubular sling 102. Bonding may be accomplished by way ofany suitable approach, including gluing, heat bonding and/or tying. Inthe illustrative example, the dilator 104 is hollow. Similarly, thedilator 106 has a generally cylindrical portion 106 a and a generallyconical portion 106 b extending axially from the cylindrical portion 106a. The conical portion 106 b tapers smaller toward and terminates in anaperture 106 c. A terminal end 106 d of the cylindrical portion 106 abonds to the end 102 b of the tubular sling 102. As in the case of thesling end 102 a, bonding may be accomplished by way of any suitableapproach, including gluing, heat bonding and/or tying. In theillustrative example, the dilator 106 is also hollow. It should be notedthat although the illustrative embodiment depicts the sling assembly asincluding the dilators 104 and 106, this need not be the case. By way ofexample, any suitable end caps 104 and 106 may be used, which may or maynot provide a tissue dilation function. Additionally, no end caps 104and 106 at all may be employed, instead attaching the dilator ends ofthe below described filaments to the sling ends themselves.

The sling 102 is depicted as being formed from a synthetic mesh, butthis need not be the case. The sling 102 may be formed from any suitablematerial, synthetic, natural (e.g., biological) or a combinationthereof. The sling also need not be configured as a mesh. An importantfeature of the sling 102 is that it has multiple shape states. Thus, anymaterial that provides the same or similar shape states may be employed.More specifically, the sling 102 may be in an untensioned state, fullytensioned or any state in between. The sling may be fabricated from anyof a number of biocompatible materials, such as nylon, polyethylene,polyester, polypropylene, fluoropolymers, copolymers thereof,combinations thereof, or other suitable synthetic material(s). Thematerial may be, for example, a synthetic material that is absorbable bythe patient's body. Suitable absorbable synthetic materials can includepolyglycolic acid, polylactic acid, and other suitable absorbablesynthetic materials. Alternatively, the material for the sling may bederived from mammalian tissue(s) or a combination of mammalian tissue(s)and synthetic material(s). The sling material may be fabricated from oneor more yams, which yams may be made from one or more materials. Thesling may incorporate or be coated with one or more agents to provide atherapeutic effect, for example, to reduce discomfort, to reduce thechance of infection and/or to promote tissue growth.

In the untensioned state of FIG. 1A, the sling 102 has a diameter 116near a mid point, which is smaller than a similarly central diameter,such as the diameter 116 of FIG. 1B, taken in a more or fully tensionedstate. Also, in the untensioned state of FIG. 1A, the sling 102 has alength 118, which is longer than a length, such as the length 118 ofFIG. 1B, taken in the more or fully tensioned state. Thus, as the slingbecomes more tensioned, its diameter (which translates into its widthwhen the sling is fattened) expands and its length contracts. Similarly,as the sling becomes less tensioned, its length expands and its diametercontracts. According to the illustrative embodiment, the length 118 ofthe sling 102 in the narrowed state of FIG. 1A is between about 9 cm toabout 13 cm, and is between about 5 cm to about 9 cm in the widenedstate of FIG. 1B. In one illustrative embodiment, the length 117 of FIG.1A is about 7 cm. According to a further illustrative embodiment, thelength 118 of FIG. 1B is about 11 cm.

Another important feature of the sling 102 is that its tubularconfiguration provides an axially extending passage 102 c through whichthe filaments 112 and 114 pass. As shown, the filament 112 has an anchorend 112 a and a sling end 112 b. The sling end 112 b of the filament 112threads into the dilator 104 through the aperture 104 c in the conicalportion 104 b, through the hollow body of the dilator 104 and out thecylindrical end 104 d of the dilator 104. The aperture 104 c and thefilament 112, illustratively, are sized to enable the filament 112 toslide easily through the aperture 104 c. The sling end 112 b of thefilament 112 then threads axially through the passage 102 c in thecylindrically configured sling 102, through the cylindrical end 106 d ofthe dilator 106, and anchors to the dilator 106. In the illustrativeembodiment, the sling end 112 b of the filament 112 is glue bonded to aninner surface of the cylindrical end 106 d of the dilator 106. However,the filament end 112 b may be bonded to the dilator 106 in any suitablemanner and to any suitable location on the dilator 106. By way ofexample, the filament end 112 b may be tied, heat bonded or formedintegrally with the dilator 106.

The anchor end 112 a of the filament 112 attaches to the anchor 108. Theanchor 108 may be of any suitable shape. In the illustrative embodimentof FIGS. 1A and 1B, the anchor 108 is cylindrical and hollow in nature,about 2 cm long and has a through aperture 108a in a side wall. Thefilament end 112 a interfits through the aperture 108 a and is bondedwithin the anchor 108. The filament end 112 a may be bonded with theanchor 108 in any suitable manner, including without limitation, gluebonded, tied, knotted or crimped. The filament 112 is preferably formedfrom a flexible polymer or metal. In some illustrative embodiments, itmay be formed from any suitable suturing material. With the aperture 108a located near a middle location along a length of the anchor 108, theanchor 108 tends to form a T-configuration with the filament 112, whichtends to resist removal of the sling 102 when embedded in soft tissue.

In a similar fashion to the filament 112, and as shown in FIGS. 1A and1B, the filament 114 has an anchor end 114 a and a sling end 114 b. Thesling end 114 b of the filament 114 threads into the dilator 106 throughthe aperture 106 c in the conical portion 106 b, through the hollow bodyof the dilator 106 and out the cylindrical end 106 d of the dilator 106.The aperture 106 c and the filament 114, illustratively, are sized toenable the filament 114 to slide easily through the aperture 106 c. Thesling end 114 b of the filament 114 then threads axially through thepassage 102 c in the cylindrically configured sling 102, through thecylindrical end 104 d of the dilator 104, and anchors to the dilator104. In the illustrative embodiment, the sling end 114 bof the filament114 is glue bonded to an inner surface of the cylindrical end 104 d ofthe dilator 104. However, the filament end 114 b may be bonded to thedilator 104 in any suitable manner and to any suitable location on thedilator 104. By way of example, the filament end 114 b may be tied, heatbonded or formed integrally with the dilator 104.

The anchor end 114 a of the filament 114 attaches to the anchor 110. Asin the case of the anchor 108, the anchor 110 may be of any suitableshape. In the illustrative embodiment of FIGS. 1A and 1B, the anchor 110is cylindrical and hollow in nature, about 2 cm long and has a throughaperture 110 a in a side wall. The filament end 114 a interfits throughthe aperture 110 a and is bonded within the anchor 110. The filament end114 a may be bonded with the anchor 110 in any suitable manner,including without limitation, glue bonded, tied, knotted or crimped. Thefilament 114 is preferably formed from a flexible polymer or metal. Insome illustrative embodiments, it may be formed from any suitablesuturing material.

In operation, pulling on the filament 112, while holding the anchor 110(and thus, the filament 114) stationary, pulls the dilator 106 along thefilament 114 in the direction indicated by the arrow 120, causing thelength 118 of the sling 102 to decrease, for example, from that shown inFIG. 1A to that shown in FIG. 1B. It also causes the diameter 116 toincrease, for example, from that shown in FIG. 1A to that shown in FIG.1B.

In a similar fashion, pulling on the filament 114, while holding theanchor 108 (and thus, the filament 112) stationary, pulls the dilator104 along the filament 112 in the direction indicated by the arrow 122,also causing the length 118 of the sling 102 to decrease, for example,from that shown in FIG. 1A to that shown in FIG. 1B. It also causes thediameter 116 to increase, for example, from that shown in FIG. 1A tothat shown in FIG. 1B. Pulling on both filaments 112 and 114 also hassimilar effects on the sling length 118 and sling width 116. Thisfeature enables the sling 102 to be sized, shaped and tensioned in acustom manner, both prior and subsequent to delivery to an anatomicalsite, such as the periurethral tissue in the body of a patient.

FIG. 1C depicts a sling assembly 100 according to an alternativeillustrative embodiment of the invention. In contrast to FIG. 1B, theend 1126 of the filament 112 attaches to the dilator 104, and the end1146 of the filament 114 attaches to the dilator 106. In thisalternative configuration, the filament ends 112 a and 114 a threadthrough the sling 102 and out the sling mesh at an intermediate locationbetween the dilators 104 and 106. According to the illustrativeembodiment of FIG. 1C, the filament ends 112 a and 114 a emerge from thesling mesh 102 at approximately a midpoint between the dilator 104 andthe dilator 106. However, this need not be the case.

According to the illustrative embodiment of FIG. 1C, the filaments 112and/or 114 can be adjusted, for example, via a vaginal incisionsubsequent to implementation, to position and/or tension the sling 102.The filament ends 112 a and 114 a also can be tied, knotted, crimped, orotherwise bonded to maintain the correct tension and position of thesling 102. This also maintains the length 118 and the width 116 of thesling 102.

A tubular sling assembly of the invention may also include a sleeve forcovering, at least partially, the tubular sling 102 during implantation.The sleeve may be made, for example, from one or more absorbentmaterials, such as a sponge-like material, that can optionally bepre-soaked in a drug solution, for example, in an anesthetic,anti-inflammatory, coagulating, anticoagulating, or antibiotic solution.In another embodiment, the sleeve may be made from a non-wettablematerial, such as polypropylene, polyethylene, polyester,polytetrafluoroethylene (available from DuPont Corporation, Wilmington,Del., under the trademark TEFLON®), TYVEK®, MYLAR®, or co-polymersthereof. The non-wettable materials can also be pretreated with atherapeutically effective drug coating. The sleeve is preferablytransparent so that an operator will be able to see the implantable,tubular sling inside the sleeve. The sleeve is also preferably made fromexpandable materials such that it will not constrain the expansion ofthe tubular sling enclosed, at least partially, therein.

According to the illustrative embodiment, the diameter 116 of thetubular sling 102 is about 0.5 cm to about 2 cm before expansion, andthe length 118 is about 4 cm to about 20 cm length before expansion. Inother embodiments, the diameter 116 is less about 0.5 cm, 0.4 cm, 0.3cm, or 0.2 cm. The dilators 106 and 108 may have similar outsidediameters to that of the sling 102. In certain embodiments employing asleeve covering, at least partially, the sling, the sling ends do notattached to the sleeve. This feature enables a medical operator to pullon the ends of the sleeve during sling assembly placement, and/or any ofthe delivery devices if associated with the sleeve rather than thesling, without risk of stretching, curling or otherwise deforming thesling 102. In certain so illustrative embodiments, the sleeve employedwith the tubular sling 102 is bioabsorpable or biodegradable.

According to various illustrative embodiments, the sling 102, afterexpansion, has a length 118 of about 5 cm to about 15 cm and a width 116of about 1 cm to about 5 cm, though the length and width of the slingmay have any suitable dimensions depending on the body part to besupported.

FIG. 2 depicts a system 200 for delivering the tubular sling assembly100 of FIGS. 1A and 1B to an anatomical site including a delivery device202 having a shaft 204 with an axially extending slot 208 in a distalportion 210 of the shaft 204 for engaging with the T-anchor 108 andtensioning filament 112 of the sling assembly 100 according to anillustrative embodiment of the invention. As depicted, the deliverydevice 202 includes a use actuator 216 at the proximal end, anactuatable pusher 220, a handle 206, and the shaft 204 extendingdistally from a distal end of the handle 206. A shaft lumen 212 extendsaxially into the shaft 204 from an opening 214 at a distal end of theshaft 204 and through the shaft 204. The shaft lumen 212 is sized andshaped for slidably receiving the T-anchor 108 of the sling assembly100, as depicted. The slot 208 extends axially into the shaft 204 fromthe opening 214 along a distal portion of the shaft lumen 212. The slot208 is sized and shaped for slidably receiving the tensioning filament112 of the sling assembly 100. A handle lumen 216 extending axiallythrough the handle 206 and axially aligns with the shaft lumen 212. Thepusher 220, by way of the user actuator 216, slides axially within thehandle lumen 216 and the shaft lumen 212. The pusher 220 is sized andshaped such that, when actuated by way of the user actuator 216, it canengage with the T-anchor 108, slide the T-anchor 108 distally and out ofthe shaft lumen 212 through the opening 214.

In use, an operator may slide the T-anchor 108 into the shaft lumen 212from the opening 214 of the shaft 204 and further slide the T-anchor 108distally such that the tensioning filament 112 is received by the slot208. To dissociate the T-anchor 108 and thus the sling assembly 100 fromthe delivery device 202, the operator can actuate the user actuator 216and slide the pusher 220 distally along the handle lumen 216 and theshaft lumen 212 to push the T-anchor 108 out of the shaft lumen 212through the opening 214. An advantage of the slot 208 and the shaft 204design is that the T-anchor 108 can remain free to slide along the slot208. When slid to a proximal most position in the slot 208 during theinsertion of the delivery device 202 into a body of a patient, theT-anchor 108 remains engaged with the slot 208 such that the slingassembly 100 remains associated with the delivery device 202. Duringwithdrawal of the delivery device 202, the T-anchor 108 can be, by wayof the user actuator 216 and the pusher 220, easily slid distally offthe shaft 204 of the delivery device 202, thus dissociating the slingassembly 100 from the delivery device 202 and leaving the T-anchor 108in an anatomical site of the patient.

The depicted configuration is suitable for delivering a sling assemblywith a transvaginal, prepubic, or inside-out transobtural approach,which includes associating the sling assembly 100 with the deliverydevice 202 before inserting the delivery device 202 into a patient'sbody. For example, in a single-incision, prepubic approach, the deliverdevice 202, with the associated sling assembly 100, is inserted into apatient's body through a vaginal incision, and the T-anchor 108 is thenplaced at a desired anatomical location by actuating the pusher 220 todissociate the T-anchor 108, thus the sling assembly 100, from thedelivery device 202. The T-anchors may be delivered to any suitablelocation. By way of example, a medical operator may place the T-anchors,without limitation, between the ischiocavernous pubic muscle andischiopubic bone; behind the pubic bone; in front of, embedded within,or through the obturator membrane; or within any suitable ligaments orother tissue structures.

The delivery device 202 is then withdrawn from the patient's body. Thesame delivery device 202 or a different delivery device may be used toimplant the other T-anchor 110, thus the entire sling assembly 100. TheT-anchor 110 can be placed in a similar manner at an anatomical locationon the opposite side of the urethra from the anatomical site where theT-anchor 108 is placed. During placement of the T-anchor 110, thetensioning filament 114 is being pulled, while the T-anchor 108, by wayof tissue anchoring, effectively holds the tensioning filament 112substantially stationary. Thus, implanting the T-anchor 110 to a desiredanatomical site effectuates movement of the dilator 104 axially alongthe tensioning filament 112 to effectively shorten the length of thesling, resulting in widening of the sling 102 along at least a middleportion. The T-anchor 110, and thus the sling assembly 100, can then bedissociated from the delivery device, leaving the sling 102 implantedwith a desirable length and width.

A sling assembly end may have other configurations, for example, thesling assembly end having a guide tube or an association tube asdescribed in U.S. patent applications Ser. No. 10/973,010. Similarly, adistal end or portion of a delivery device may have otherconfigurations, for example, the delivery device having a shoulder nearits distal end or a forked distal tip as described in U.S. patentapplications Ser. No. 10/973,010 or the delivery device having a L-slotlocated near its distal end, as described in U.S. patent applicationSer. No. 10/957,926. The delivery device may also include a pusherassembly that interfits with and over the shaft of the delivery device,as described in U.S. patent applications Ser. No. 10/973,010. All of theabove applications are incorporated herein by reference.

Referring back to FIG. 2, the shaft 204 also includes a distal tip 218.As depicted, the distal tip 218 is sharp. However, a shaft of a deliverydevice of the invention may alternatively employ a differentconfiguration. The distal tip or distal end of a shaft may be shaped tofacilitate insertion of the shaft into the tissue of a patient, forexample, being rounded, beveled, pointed, or any other suitable shape.

Also referring to FIG. 2, the shaft 204 and/or the handle 206 of thedelivery device 202 are both substantially straight. However, inalternative embodiments, the shaft 204 and/or the handle 206 may includeone or more curved sections. Additionally, the shaft 204 and/or thehandle 206 may lie substantially in one plane or may be shaped to lie inmultiple planes. The shaft 204 may be of substantially constant outsidediameter or may include portions of differing outside diameters. Invarious embodiments, the shaft may include hooked and/or helicalportions. The shaft may also be configured in various ways and/orinclude various features as described in the patents and patentapplications referenced herein. Similarly, the handle 206 may also beconfigured in various ways and/or include various features as describedin, e.g., U.S. Provisional Patent Application Ser. Nos. 60/508,600 and60/569,300, the disclosures of which are incorporated herein byreference.

FIG. 3 depicts an alternative system 300 for delivering the tubularsling assembly 100 to an anatomical site including a delivery device 302having a shaft 304 with a notch 306 and at least one axially extendingslot 308 along a side of a distal portion 310 for engaging with theT-anchor 108 and the tensioning filament 112 of the sling assembly 100according to an illustrative embodiment of the invention. As depicted,the delivery device 302 includes, at its proximal end, a user actuator316 and an actuatable pusher 320. The delivery device 302 furtherincludes a handle 306 which has a handle lumen 312 extending axiallythrough the handle 306. The shaft 304 extends distally from a distal endof the handle 306 and has a shaft lumen 314 extending axially throughthe shaft 304. The handle lumen 312 and the shaft lumen 314 axiallyalign with each other such that the pusher 320 can be actuated, by wayof the actuator 316, and slid axially within the handle lumen 312 andthe shaft lumen 314.

Referring to FIG. 3, the slot 308 extends proximally for a distalportion of the shaft lumen 314. The slot 308 is sized and shaped forslidably receiving the tensioning filament 112 of the sling assembly100. Unlike the slot 208 as depicted in FIG. 2, the slot 308 does notextend axially from a distal opening 318 of the shaft 304. The notch 306extends axially from a proximal end of the slot 308 and has a width 324that is larger than a width 326 of the slot 308. The notch 306 islocated along a portion of the shaft lumen 314 and exposes that portionof the shaft lumen 314. The notch 306 is also sized and shaped forseating the T-anchor 108 within the exposed lumen of the shaft 314 andfor easily removing the T-anchor 108 when the entire T-anchor 108 islocated between a proximal end and a distal end of the notch 306.

In use, an operator may place the T-anchor 108 within the portion of theshaft lumen 314 exposed by the notch 306. By way of the actuator 316,the pusher 320 is slid distally and axially within the handle lumen 312and the shaft lumen 314 and engages with the T-anchor 108 seated in thenotch 306. By further sliding the pusher 320 distally, the T-anchor 108is slid axially within the shaft lumen 314, and the tensioning filament112 becomes engaged with the slot 308. To dissociate the T-anchor 108from the delivery device 302, the operator can slide the pusher 320proximally within the handle lumen 312 and the shaft lumen 314, by wayof the actuator 316, thus causing the T-anchor 108 to slide distallywithin the shaft lumen 314 and move into the notch 306. The T-anchor 108can easily disengage from the notch 306 when the entire length of theT-anchor 108 falls within a proximal end and a distal end of the notch306.

As in the case of the delivery device 202 of FIG. 2, the depictedconfiguration of FIG. 3 is also suitable for delivering a sling assemblyto an anatomical site in a patient's body by various approaches, forexample, a transvaginal, inside-out transobturator, or prepubicapproach. These approaches include associating a sling assembly end witha delivery device 302 before inserting the delivery device 302 into thepatient's body through a vaginal incision. Alternatively, the deliverydevice 302 may be used to deliver a sling assembly to an anatomical sitein a patient's body by a suprapubic (abdominal), outside-intransobtural, or top-down prepubic approach. Each of these approachesinclude inserting the delivery device 302 into the patient's bodythrough an abdominal, ischiopubic, or other non-vaginal incision beforeassociating a sling assembly end with the delivery device.

According to an alternative configuration, an external pusher 328 may beemployed with the delivery device 302. In this configuration, thedelivery device 302 may or may not include, at its proximal end, anactuator and an actuatable pusher, such as the depicted actuator 316 andthe pusher 320. In use, an operator may place the T-anchor 108 in thenotch 306 and slide the T-anchor 108 axially within the shaft lumen 314to engage the tensioning filament 112 with the slot 308. To dissociatethe T-anchor 108, and thus the sling assembly 100, from the deliverydevice 302, the operator slides the external pusher 328 into the shaftlumen 314 by way of the distal opening 318 of the shaft 304. The pusher328 engages with the T-anchor 108, and further sliding of the pusher 328proximally within the shaft lumen 314 causes the T-anchor 108 to slideproximally within the shaft lumen 314 and into the notch 306. TheT-anchor 108 can easily disengage from the notch 306 when the entirelength of the T-anchor 108 falls within a proximal end and a distal endof the notch 306.

As depicted, the notch 306 extends from a proximal end of the slot 308.According to an alternative configuration, a notch that is sized andshaped substantially the same as the notch 306 may extend from a distalend of a slot that extends along a side of a shaft of a delivery deviceand is sized and shaped substantially the same as the slot 308.

FIG. 4 depicts another alternative system 400 for delivering a slingassembly, such as the tubular sling assembly 100, to an anatomical sitein a patient's body. The system 100 includes a delivery device 402having a handle 412 and a shaft 404 extending distally from the handle412. The handle 412 includes an axially extending through lumen 414. Theshaft 404 also includes a lumen 416 in axially alignment with andextending distally from the handle lumen 414 along at least a portion ofthe length of the shaft 404. The shaft 404 includes a notch 406 thatexposes a portion of the shaft lumen 416, and is sized and shaped toreadily receive and release the T-anchor 108. The delivery device 402includes a cannula assembly, which has a user actuator 408 located at aproximal end of the delivery device 402, and a cannula 410 extendingdistally from the actuator 408 through the handle lumen 414 and theshaft lumen 416. The cannula 410 is sized and shaped such that, inresponse to the actuator 408 being pushed in a distal direction, thecannula 410 extends into the notch 406 to interfit over and cover atleast proximal portion of the T-anchor 108 to capture the T-anchor 108within the notch 406.

In use, when the notch 406 is not covered by the cannula 410, anoperator can associate the sling assembly 100 with the delivery device402 by placing the T-anchor 108 within the notch 406. The operator maythen actuate the cannula 410 and slide it distally within the handlelumen 414 and the shaft lumen 416 and into the notch 406 to interfitover and cover at least the proximal portion of the T-anchor 108. Thesling assembly 100 remains associated with the delivery device 402 inresponse to the T-anchor 108 being at least partially covered by thecannula 410. To dissociate the sling assembly 100 from the deliverydevice 402, the operator can, by way of the actuator 408, move thecannula 410 in a proximal direction within the handle lumen 414 and theshaft lumen 416 to expose the covered portion of the T-anchor 108. Thecompletely exposed T-anchor 108 can then easily disengage from the notch406.

As in the above described illustrative embodiments, the delivery device402 is suitable for delivering a sling assembly, such as the slingassembly 100, to an anatomical site in a patient's body by variousapproaches. In some approaches, the sling assembly end is associatedwith the delivery device 402 before inserting the delivery device 402into the patient's body through, for example, a vaginal incision, asdescribed above. In other approaches, the sling assembly end may beassociated with the delivery device 402 after it has been inserted intothe patient's body. Such approaches include, without limitation,suprapubic (abdominal), outside-in transobtural, and top-down prepubicapproaches, which include inserting the delivery device 402 into thepatient's body through an abdominal, ischiopubic, or other non-vaginalincision before associating it with the sling assembly end.

Referring back to FIG. 4, the shaft 404 also includes a distal tip 418.As depicted, the distal tip 418 is blunt and closed. In alternativeconfigurations, a distal tip or distal end of a shaft may be shaped tofacilitate insertion of the shaft into the tissue of a patient, forexample, rounded, beveled, pointed, or any other suitable shape. Alsoreferring to FIG. 4, the shaft lumen 416 extends distally from a distalend of the notch 406, but does not extend through the distal tip 418. Inalternative configurations, the shaft 404 has a solid distal portionthat extends distally from a distal end of the notch 406.

As described above with respect to FIG. 1C, in some illustrativeembodiments, the sling assembly of the invention does not includeanchors, such as the anchors 108 and 110 of FIG. 1A. Instead, the slingassembly may include no anchors, or alternatively, the end caps 104 and106 may include radial projections sized and shaped for allowing the endcap to pass into tissue, but resisting being removed. Exemplary endcaps/anchors that may be used with the invention are disclosed, withoutlimitations, in U.S. Ser. No. 11/152,898, entitled “SYSTEMS, METHODS,AND DEVICES RELATING TO IMPLANTABLE SUPPORTIVE SLINGS,” filed on Jun.14, 2005, the entire contents of which are incorporated herein byreference.

In such embodiments, a delivery device shaft, such as the shaft 500 ofFIG. 5, may be employed for implanting the sling assembly of FIG. 1C. Asshown, the shaft 500 includes a distal section 504 and a proximalsection 502. The proximal section has a diameter 510 less than thediameter 508 to form a shoulder 506.

In operation, each end cap 104 and 106 interfits one at a time over thedistal section 504 of the shaft 500. The shoulder 506 inhibits the endcaps 104 and 106 from sliding proximally along the shaft section 502.According to some illustrative embodiments, to such delivery deviceshafts may be employed, one for each end cap 104 and 106. A deliverydevice of the type depicted in FIG. 5C, along with other deliverydevices suitable for use with the illustrative embodiment of FIG. 1C aredisclosed, without limitation, in U.S. Ser. No. 10/973,010, entitled“SYSTEMS AND METHODS FOR SLING DELIVERY AND PLACEMENT,” filed on Oct.25, 2004 and in U.S. Ser. No. 11/180,167, entitled “SNAP FIT SLINGANCHOR SYSTEM AND RELATED METHODS” filed on Jul. 13, 2005,the entirecontents of which are incorporated herein by reference.

Preferably, the delivery devices and/or delivery assemblies of theinvention are made of biocompatible materials, which can include, forexample, polyethylene/ethylene vinyl acetate (EVA) blend, polyethylene,polyester, nylon, polypropylene, thermoplastic fluorinated ethylenepropylene (FEP), TFP, stainless steel, malleable metal or anycombination of these materials. Preferably, a shaft of a delivery deviceof the invention is formed of surgical grade stainless steel.

As described above with regard to FIG. 1 and the sling assembly 100, animportant advantage of the sling assembly 100 is that its length andwidth may be easily adjusted during a sling implantation procedure. Thisfeature is particularly helpful when the sling assembly includes endshaving an integral anchoring or other mechanism, such as in the case ofthe sling assembly 100. More particularly, with any useful mechanism onthe sling end, it may not be desirable to cut the end off to adjust thelength of the sling. Instead, the sling may need to be cut or otherwiseshortened from the middle and then, in the case of cutting, reboundedtogether. Another important advantage of the sling assembly 100 is thatsince the width may be increased subsequent to insertion into the body,in an initial elongated state, it need not be wide enough to perform itssupportive functions. The reduced width initial state makes it easierfor the sling to travel through tunnels created by the delivery device,reducing both tissue irritation and unwanted sling deformation.Additionally, the tubular shape of the sling does not include anyelongated edges that may curl, distort or otherwise deform duringimplantation, thus making it inherently more stable than flat, sheetlike, sling counterparts.

Referring once again to FIG. 1, in an illustrative implantation methodof the invention, a medical operator may employ any suitable deliverydevice, including those described above, to implant any suitable firstanchor, such as the anchor 108 of the sling assembly 102 at a firstanatomical site in the body of the patient with the sling assembly 100in an elongated, width reduced state. Implanting the first anchor 108essentially fixes the location of the anchor end 112 a of the filament112. Next, the medical operator places the second anchor 110 at adesired second anatomical site in the body of the patient. By adjustingthe distance between the first and second anchors, the medical operatorcan adjust both the length and width of the sling 102, without need forany cutting, clipping or other modification to the sling 102. Morespecifically, as the medical operator increases the distance between thefirst anatomical site and the second anatomical site, the sling end 114b of the second filament 114 pulls the dilator 104 along the firstfilament 112 toward the second anchor 110. Similarly, the sling end 112b of the first filament 112 pulls the dilator 106 along the secondfilament 114 toward the first anchor 108. As described above withrespect to FIG. 1, this effectively reduces the length of the sling 102.Also, due to the woven tubular configuration of the sling 102, the widthof the sling increases as the length decreases. According to analternative methodology, the medical operator fixes the location of oneof the sling ends to allow only the other of the sling ends to travelalong the respective filament.

According to another advantage, subsequent to implantation, the dilator104 and 106 may continue to move along their respective filaments tochange the length of the sling 102 to accommodate, for example, bodymovement, muscle contractions, or other physical changes in the body ofthe patient. This feature also effectively adjusts the tension of thesling 102 and helps to prevent the sling 102 from becoming overtensioned as result of body changes/movements.

Another important feature of the sling 102 is that its tubularconfiguration provides an axially extending passage 102 c through whichthe filaments 112 and 114 pass. As shown, the filament 112 has an anchorend 112 a and a sling end 112 b. The sling end 112 b of the filament 112threads into the dilator 104 through the aperture 104 c in the conicalportion 104 b, through the hollow body of the dilator 104 and out thecylindrical end 104 d of the dilator 104. The aperture 104 c and thefilament 112, illustratively, are sized to enable the filament 112 toslide easily through the aperture 104 c. The sling end 112 b of thefilament 112 then threads axially through the passage 102 c in thecylindrically configured sling 102, through the cylindrical end 106 d ofthe dilator 106, and anchors to the dilator 106. In the illustrativeembodiment, the sling end 112 b of the filament 112 is glue bonded to aninner surface of the cylindrical end 106 d of the dilator 106. However,the filament end 112 b may be bonded to the dilator 106 in any suitablemanner and to any suitable location on the dilator 106. By way ofexample, the filament end 112 b may be tied, heat bonded or formedintegrally with the dilator 106.

In a similar fashion to the filament 112, and as shown in FIGS. 1A and1B, the filament 114 has an anchor end 114 a and a sling end 114 b. Thesling end 114 b of the filament 114 threads into the dilator 106 throughthe aperture 106 c in the conical portion 106 b, through the hollow bodyof the dilator 106 and out the cylindrical end 106 d of the dilator 106.The aperture 106 c and the filament 114, illustratively, are sized toenable the filament 114 to slide easily through the aperture 106 c. Thesling end 114 b of the filament 114 then threads axially through thepassage 102 c in the cylindrically configured sling 102, through thecylindrical end 104 d of the dilator 104, and anchors to the dilator104. In the illustrative embodiment, the sling end 114 bof the filament114 is glue bonded to an inner surface of the cylindrical end 104 d ofthe dilator 104. However, the filament end 114 b may be bonded to thedilator 104 in any suitable manner and to any suitable location on thedilator 104. By way of example, the filament end 114 b may be tied, heatbonded or formed integrally with the dilator 104.

The anchor end 114 a of the filament 114 attaches to the anchor 110. Asin the case of the anchor 108, the anchor 110 may be of any suitableshape. In the illustrative embodiment of FIGS. 1A and 1B, the anchor 110is cylindrical and hollow in nature, about 2 cm long and has a throughaperture 110 a in a side wall. The filament end 114 a interfits throughthe aperture 110 aand is bonded within the anchor 110. The filament end114 a may be bonded with the anchor 110 in any suitable manner,including without limitation, glue bonded, tied, knotted or crimped. Thefilament 114 is preferably formed from a flexible polymer or metal. Insome illustrative embodiments, it may be formed from any suitablesuturing material.

In operation, pulling on the filament 112, while holding the anchor 110(and thus, the filament 114) stationary, pulls the dilator 106 along thefilament 114 in the direction indicated by the arrow 120, causing thelength 118 of the sling 102 to decrease, for example, from that shown inFIG. 1A to that shown in FIG. 1B. It also causes the diameter 116 toincrease, for example, from that shown in FIG. 1A to that shown in FIG.1B.

The inventions described herein, for example, with regard to deliverydevices and anchors may be employed with any suitable sling or slingassembly, and any suitable sling delivery approach. Similarly, theinventions described herein relating to sling assemblies may be employedwith any suitable delivery devices or approaches, any suitable slingassembly-to-delivery device association mechanism, and suitableanchoring mechanism or none at all.

Without limitation, examples of slings, sling assemblies, sling deliverydevices and approaches, sling assembly-to-delivery device associationmechanisms, and sling anchoring mechanisms including features with whichthe invention may be employed are disclosed in U.S. Pat. No. 6,042,534,entitled “Stabilization sling for use in minimally invasive pelvicsurgery,”U.S. Pat. No. 6,755,781, entitled “Medical slings,” U.S. Pat.No. 6,666,817, entitled “Expandable surgical implants and methods ofusing them,” U.S. Pat. No. 6,042,592, entitled “Thin soft tissuesurgical support mesh,” U.S. Pat. No. 6,375,662, entitled “Thin softtissue surgical support mesh,” U.S. Pat. No. 6,669,706, entitled “Thinsoft tissue surgical support mesh,” U.S. Pat. No. 6,752,814, entitled“Devices for minimally invasive pelvic surgery,” U.S. Ser. No.10/918,123, entitled “Surgical Slings,” U.S. patent application Ser. No.10/641,376, entitled “Spacer for sling delivery system,” U.S. patentapplication Ser. No. 10/641,192, entitled “Medical slings,” U.S. Ser.No. 10/641,170, entitled “Medical slings,” U.S. Ser. No. 10/640,838,entitled “Medical implant,” U.S. patent application Ser. No. 10/460,112,entitled “Medical slings,” U.S. patent application Ser. No. 10/631,364,entitled “Bioabsorbable casing for surgical sling assembly,” U.S. Ser.No. 10/092,872, entitled “Medical slings,” U.S. patent application Ser.No. 10/939,191, entitled “Devices for minimally invasive pelvicsurgery,”U.S. patent application Ser. No. 10/774,842, entitled “Devicesfor minimally invasive pelvic surgery,” U.S. patent application Ser. No.10/774,826, entitled “Devices for minimally invasive pelvic surgery,”U.S. Ser. No. 10/015,114, entitled “Devices for minimally invasivepelvic surgery,” U.S. patent application Ser. No. 10/973,010, entitled“Systems and methods for sling delivery and placement,” U.S. patentapplication Ser. No. 10/957,926, entitled “Systems and methods fordelivering a medical implant to an anatomical location in apatient,”U.S. patent application Ser. No. 10/939,191, entitled “Devicesfor minimally invasive pelvic surgery,” U.S. patent application Ser. No.10/918,123, entitled “Surgical slings,” U.S. patent application Ser. No.10/832,653, entitled “Systems and methods for sling delivery andplacement,” U.S. patent application Ser. No. 10/642,397, entitled“Systems, methods and devices relating to delivery of medical implants,”U.S. patent application Ser. No. 10/642,395, entitled “Systems, methodsand devices relating to delivery of medical implants,” U.S. patentapplication Ser. No. 10/642,365, entitled “Systems, methods and devicesrelating to delivery of medical implants,” U.S. patent application Ser.No. 10/641,487, entitled “Systems, methods and devices relating todelivery of medical implants,” U.S. patent application Ser. No.10/094,352, entitled “System for implanting an implant and methodthereof,” U.S. patent application Ser. No. 10/093,498, entitled “Systemfor implanting an implant and method thereof,” U.S. patent applicationSer. No. 10/093,450, entitled “System for implanting an implant andmethod thereof,” U.S. patent application Ser. No. 10/093,424, entitled“System for implanting an implant and method thereof,” U.S. patentapplication Ser. No. 10/093,398, entitled “System for implanting animplant and method thereof,” and U.S. patent application Ser. No.10/093,371, entitled “System for implanting an implant and methodthereof,” the entire contents of all of which are incorporated herein byreference.

1. A delivery device comprising, a handle, and a shaft extendingdistally from a distal end of the handle and including, a shaft lumenaxially extending near a distal end of the shaft, the shaft lumen beingsized and shaped for slidably receiving an anchor of a sling assembly,and a slot extending axially along at least a portion of the shaftlumen, the slot being sized and shaped for slidably receiving a filamentattached to an anchor received in the shaft lumen.
 2. The deliverydevice of claim 1, wherein the shaft lumen extends axially into theshaft from an opening in the distal end of the shaft, the opening beingsized and shaped for receiving an anchor of a sling assembly into theshaft lumen.
 3. The delivery device of claim 2, wherein the slot extendsaxially in a proximal direction from the opening in the distal end ofthe shaft.
 4. The delivery device of claim 2, wherein the slot extendsproximally for an entire length of the shaft lumen.
 5. The deliverydevice of claim 2, wherein the slot extends proximally for a portion ofa length of the shaft lumen.
 6. The delivery device of claim 3, whereinthe handle includes a handle lumen extending axially through the handleand the shaft lumen extends distally to a distal end of the shaft andaxially aligns with the handle lumen, and the delivery device includes apusher assembly, the pusher assembly including pusher and a useractuator for sliding the pusher axially within the shaft and handlelumens.
 7. The delivery device of claim 1 comprising a notch having awidth greater than a width of the slot, located along a portion of theshaft lumen, and extending axially from an end of the slot.
 8. Thedelivery device of claim 7, wherein the notch extends proximally from aproximal end of the slot.
 9. The delivery device of claim 7, wherein theshaft lumen extends distally to an opening in a distal end of the shaft,the opening being sized and shaped for receiving an anchor of a slingassembly into the shaft lumen.
 10. The delivery device of claim 9comprising a pusher sized and shaped for insertion into the opening inthe distal end of the shaft and for extending at least to a distal endof the notch.
 11. The delivery device of claim 7, wherein the notchextends distally from a distal end of the slot.
 12. The delivery deviceof claim 7, wherein the notch is sized and shaped for receiving ananchor of a sling assembly into the shaft lumen.
 13. The delivery deviceof claim 7, wherein a portion of the shaft lumen extends distally from adistal end of the notch.
 14. The delivery device of claim 7, wherein aportion of the shaft lumen extends proximally from a proximal end of thenotch.
 15. The delivery device of claim 7, wherein the handle includes ahandle lumen extending axially through the handle and the shaft lumenextends distally to a distal end of the shaft and axially aligns withthe handle lumen, and the delivery device includes a pusher assembly,the pusher assembly including pusher and a user actuator for sliding thepusher axially within the shaft and handle lumens, at least to aproximal end of the notch.
 16. The delivery device of claim 15, whereinthe user actuator axially slides the pusher within the shaft and handlelumens at least to a distal end of the notch.
 17. A delivery devicecomprising, a handle, and a shaft extending distally from a distal endof the handle and including, a shaft lumen axially extending near adistal end of the shaft, the shaft lumen being sized and shaped forslidably interfitting with an anchor of a sling assembly, and a notchextending axially along at least a portion of the shaft lumen, the notchbeing sized and shaped for receiving an anchor of a sling assembly intothe shaft lumen.
 18. The delivery device of claim 17, wherein the handleincludes a handle lumen extending axially through the handle and theshaft lumen extends distally to a distal end of the shaft and axiallyaligns with the handle lumen, and the delivery device includes a cannulaassembly, the cannula assembly including cannula and a user actuator forsliding the cannula axially within the shaft and handle lumens and atleast partially into the notch.
 19. A sling assembly comprising, animplantable supportive sling having a tubular shape defining an outerside for supporting a urethra of a patient, an inner side and an axialpassage extending on the inner side between first and second ends, afirst tensioning filament attached at the first end of the sling andextending through the axial passage and out the second end of the sling,and a second tensioning filament attached to the second end of the slingand extending through the axial passage and out the second end of thesling.
 20. The sling assembly of claim 19 comprising, a first end capattached to the first end of the sling and a second end cap attached tothe second end of the sling, the first and second end caps havingthrough apertures, wherein the first tensioning filament attaches to thefirst end of the sling by way of the first end cap and extends out ofthe second end of the sling by way of the through aperture of the secondend cap, and wherein the second tensioning filament attaches to thesecond end of the sling by way of the second end cap and extends out ofthe first end of the sling by way of the through aperture of the firstend cap.
 21. The sling assembly of claim 20, wherein the first andsecond end caps have tapered portion to provide for tissue dilationduring sling implantation.
 22. The sling assembly of claim 19, whereinthe sling is a mesh sling.
 23. The sling assembly of claim 19, whereinthe sling is woven sling.
 24. The sling assembly of claim 19 comprisinga first anchor attached to a terminal end of the first tensioningfilament and a second anchor attached to a terminal end of the secondtensioning filament.
 25. A system for treating urinary incontinencecomprising: a sling assembly including, an implantable supportive slinghaving a tubular shape defining an outer side for supporting a urethraof a patient, an inner side and an axial passage extending on the innerside between first and second ends, a first tensioning filament attachedat the first end of the sling and extending through the axial passageand out the second end of the sling, and a second tensioning filamentattached to the second end of the sling and extending through the axialpassage and out the second end of the sling; and a delivery device forimplanting the sling in periurethral tissues of the patient toameliorate urinary incontinence.
 26. The system of claim 25, wherein thesling assembly includes a first anchor attached to a terminal end of thefirst tensioning filament and a second anchor attached to a terminal endof the second tensioning filament.
 27. The system of claim 26, whereinthe delivery device includes, a handle, and a shaft extending distallyfrom a distal end of the handle and including, a shaft lumen axiallyextending near a distal end of the shaft, the shaft lumen being sizedand shaped for slidably receiving at least one of the first and secondanchors of the sling assembly, and a slot extending axially along atleast a portion of the shaft lumen, the slot being sized and shaped forslidably receiving at least one of the first and second tensioningfilaments.
 28. The system of claim 26, wherein the delivery deviceincludes, a handle, a shaft extending distally from a distal end of thehandle and including, a shaft lumen axially extending near a distal endof the shaft, the shaft lumen being sized and shaped for slidablyinterfitting with at least one of the first and second anchors of thesling assembly, and a notch extending axially along at least a portionof the shaft lumen, the notch being sized and shaped for receiving atleast one of the first and second anchors of a sling assembly into theshaft lumen.
 29. A method for treating urinary incontinence comprising,delivering a first end of a sling assembly including a first end of asupportive sling to a first anatomical site in a body of a patient, anddelivering a second end of the sling assembly to a second anatomicalsite in the body of the patient to draw the first end of the supportivesling along a tensioning filament attached to the second end of thesling assembly to reduce a length and increase a width of the sling asdistance increases between the first and second anatomical sites toameliorate urinary incontinence.